Jacqueline Dini Email & Phone Number

Holbrook, Ny, Us

Vers-Chez-Les-Blanc, Vaud, Ch

Ronkonkoma, Ny, Us

• Revised product labeling to ensure consistency with reference listed drug by incorporating RLD updates, Sandoz Guidelines and FDA Labeling Trends to ANDA products, as well as conversion of product inserts to PLR format.• Ensured the implementation of FDA proposed changes are accurately reflected in the Final Printed Labeling required for submissions due to FDA Information Requests, Supplement Approval Letters and ECD Letters.• Supplied Regulatory Affairs with approved labeling for FDA submissions, Side-by-Side comparisons, SPL and DailyMed Listings.• Created and revised Rx and OTC product labeling for semi solid products.• Provided all necessary documentation and files relating to new product launches and re-launches to support Regulatory, R&D and Marketing initiatives.• Assisted QA in Global initiative to implement Trackwise as the new site Change Control System.• Trackwise roles included Superuser, Change Control Coordinator, Change Control Initiator &Action Owner.• Initiated change controls in Trackwise and routed labeling artwork & supporting documentation for review & approval in Documentum.• Performed Change Control Coordinator functions required by assigning necessary evaluations & implementations to cross-functional departments• Supported Procurement in transitioning to new primary carton vendor to support company cost saving initiatives• Supplied vendors with approved artwork and assisted in proof processing for approved commercial labeling• Worked with Planning to manage implementation status of printed components• Supported Packaging Engineering & Manufacturing to ensure equipment capabilities and efficiency for manufacturing by creating test labeling required for the installation and validation of new equipment• Revised all Fougera carton templates with area required for Track and Trace serialization for accurate laser printing on production line• Current in all SOP, GOP, cGMP standards and Good Documentation Practices

• Responsible for leading and coordinating projects involving the creation of packaging for a variety of OTC pharmaceutical products (brands include Costco, Target, Rite Aid, CVS, Walgreens, Family Dollar, Walmart and Duane Reade)• Created retail packaging in compliance with customer style guides and brand image to ensure that a cohesive brand look and brand architecture was maintained• Worked directly with clients internal compliance department to ensure labeling met all legal and CFR requirements• Ensured packaging design and layout met all legal and FDA requirements while maintaining the visual identity of label and brand concepts• Interfaced with clients as needed to refine label and brand concepts to ensure client objectives were met• Coordinated with designers and vendors to meet all project requirements• Conceived and created product brand identity and distinctive package for major chain drug stores, food, beverage and wine and spirits• Developed point of purchase materials such as end cap displays, pallet skirts, bottle neckers, shelf talkers and case cards in concert with package design as part of the product/brand campaign• Effectively managed multiple projects/tasks of varying complexities, meeting deadlines and working well under pressure• Helped develop and implement company SOP to comply with FDA audits